Telemedicine Nutritional Counseling for Cancer Cachexia in Pakistan

NCT07606417 | Active Not Recruiting

• 1 other identifier: KEMU-IRB-337-RC-2026
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

What is this study about? Cancer often causes unwanted weight loss and loss of appetite, a condition called "cancer cachexia." This affects patients' strength, quality of life, and ability to tolerate cancer treatment. Proper nutrition is very important to help maintain weight and strength during cancer treatment. Currently, cancer patients receive nutritional counseling during hospital visits, which requires travel time and expense. With telemedicine (video calls on mobile phones), nutritional counseling can be provided from patients' homes. What is the purpose of this study? This study compares two ways of providing nutritional counseling to cancer patients who have experienced weight loss: Telemedicine group: Counseling through video calls (WhatsApp, Zoom, or Microsoft Teams) from home Standard care group: Counseling during in-person hospital visits Both groups receive the same nutritional advice every 2 weeks for 12 weeks. The only difference is how the counseling is delivered (video call vs. in-person). Who can participate? Adults (18 years or older) with cancer who have lost weight in recent months and have access to a smartphone with internet connection. What will participants do? Telemedicine group: Receive counseling through 20-30 minute video calls every 2 weeks (7 sessions total) Come to hospital only twice: at the beginning and end (Week 0 and Week 12) Standard care group: Come to hospital every 2 weeks for 30-45 minute counseling sessions (7 visits total) Both groups receive: Personalized dietary advice from registered dietitians Help with eating problems (poor appetite, nausea, taste changes) Pakistani meal plans that fit their preferences Free nutritional counseling throughout the study Reimbursement for travel or mobile data costs What will be measured? Body weight change over 12 weeks Food and protein intake Arm muscle measurements Nutritional status and quality of life Patient satisfaction with counseling method Costs of each method Why is this study important? This will be the first study in Pakistan and South Asia to test whether telemedicine nutritional counseling works as well as hospital visits for cancer patients. Results will help make nutritional care more accessible, especially for patients living far from hospitals. Study Location: King Edward Medical University/Mayo Hospital, Lahore, Pakistan Duration: 12 weeks per participant Total Participants Needed: 80 patients

Conditions

Cachexia; Cancer; Sarcopenia

Keywords

cachexia; nutritional counselling; telemedicine

Outcome Measures

Primary Outcomes (1)

• Change in Body Weight From Baseline to 12 Weeks

  Mean change in body weight (measured in kilograms) from baseline (Week 0) to end of intervention (Week 12). Body weight is measured using a calibrated digital scale (±0.1 kg precision) with standardized protocol: patient wearing light clothing without shoes, with empty bladder, measured at consistent time of day. Higher positive values indicate weight gain; negative values indicate weight loss. The primary objective is to assess non-inferiority of telemedicine-delivered nutritional counseling compared to standard in-person counseling, with a non-inferiority margin of -1.0 kg. Body weight is a validated, objective, clinically meaningful outcome for cancer cachexia interventions and recommended by international guidelines (ESPEN, ASCO) as a key endpoint for nutritional intervention trials in oncology.

  Baseline (Week 0) and Week 12 (end of 12-week intervention period). Measurements also collected at Week 6 (mid-point) for trajectory analysis.

Secondary Outcomes (6)

• Proportion of Participants Achieving Adequate Daily Energy Intake at 12 Weeks

  Measured at baseline (Week 0), Week 6 (mid-point), and Week 12 (end of intervention). Primary comparison at Week 12.

• Proportion of Participants Achieving Adequate Daily Protein Intake at 12 Weeks

  Measured at baseline (Week 0), Week 6 (mid-point), and Week 12 (end of intervention). Primary comparison at Week 12.

• Change in Mid-Upper Arm Circumference (MUAC) From Baseline to 12 Weeks

  Measured at baseline (Week 0), Week 6 (mid-point), and Week 12 (end of intervention). Primary endpoint is change from baseline to Week 12.

• Change in Patient-Generated Subjective Global Assessment (PG-SGA) Score From Baseline to 12 Weeks

  Measured at baseline (Week 0), Week 6 (mid-point), and Week 12 (end of intervention). Primary endpoint is change from baseline to Week 12.

• Change in Global Health Status/Quality of Life Score (EORTC QLQ-C30) From Baseline to 12 Weeks

  Measured at baseline (Week 0) and Week 12 (end of intervention). Primary endpoint is change from baseline to Week 12.

Study Arms (2)

Telemedicine Nutritional Counseling

EXPERIMENTAL

Participants receive bi-weekly nutritional counseling via video consultations using WhatsApp Video Call (primary platform), Zoom, or Microsoft Teams for 12 weeks. Registered dietitians conduct sessions from the Department of Medical Oncology, King Edward Medical University, while patients participate from home or any convenient private location with internet access.

Behavioral: Telemedicine-Delivered Nutritional Counseling

Standard In-Person Nutritional Counseling

ACTIVE COMPARATOR

Participants receive bi-weekly nutritional counseling via traditional face-to-face hospital visits for 12 weeks. Registered dietitians conduct sessions at the hospital nutrition clinic, Department of Medical Oncology, King Edward Medical University/Mayo Hospital, Lahore.

Behavioral: Standard In-Person Nutritional Counseling

Interventions

Telemedicine-Delivered Nutritional Counseling BEHAVIORAL

Bi-weekly video consultation-based nutritional counseling delivered remotely via WhatsApp Video Call (primary platform), Zoom, or Microsoft Teams. Individual one-on-one sessions lasting 20-30 minutes conducted by registered dietitians from the hospital while patients participate from their homes.

Also known as: Remote nutritional counseling, Video consultation nutrition therapy, Tele-nutrition

Telemedicine Nutritional Counseling

Standard In-Person Nutritional Counseling BEHAVIORAL

Bi-weekly in-person hospital-based nutritional counseling delivered at the hospital nutrition clinic. Individual face-to-face sessions lasting 30-45 minutes conducted by registered dietitians at the Department of Medical Oncology, King Edward Medical University/Mayo Hospital.

Also known as: Conventional nutrition counseling, Hospital-based nutritional counseling, Traditional nutritional counseling

Standard In-Person Nutritional Counseling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Age and Consent Capacity
• Age ≥18 years (adults of either biological sex or gender identity)
• Able to understand study procedures and provide written informed consent independently or with assistance from legally authorized representative 2. Cancer Diagnosis
• Histologically or cytologically confirmed solid tumor malignancy of any type, including but not limited to:
• Lung cancer (non-small cell or small cell)
• Breast cancer
• Gastrointestinal cancers: gastric (stomach), colorectal, pancreatic, esophageal, hepatobiliary (liver, gallbladder, bile duct)
• Head and neck cancers (oral cavity, pharynx, larynx, nasal cavity, salivary glands)
• Gynecological cancers: cervical, ovarian, endometrial, vulvar, vaginal
• Genitourinary cancers: prostate, bladder, renal (kidney), testicular
• Other solid tumors: sarcomas, melanoma, thyroid, brain tumors
• Any cancer stage eligible (Stage I, II, III, or IV) 3. Cancer Cachexia
• Documented unintentional weight loss meeting at least one of the following criteria:
• Weight loss ≥3% of body weight within the past 3 months, OR
• Weight loss ≥5% of body weight within the past 6 months

You may not qualify if:

• Inability to Eat Orally
• Severe dysphagia (difficulty swallowing) requiring enteral nutrition support via:
• Nasogastric tube feeding
• Percutaneous endoscopic gastrostomy (PEG) tube
• Jejunostomy tube
• Complete bowel obstruction preventing oral intake
• Total parenteral nutrition (TPN) as sole nutritional support
• Note: Partial oral intake supplemented with enteral nutrition is eligible if patient can consume at least some food by mouth 2. Refractory Cachexia
• ECOG Performance Status 3 or 4:
• Grade 3: Capable of only limited self-care; confined to bed or chair \>50% of waking hours
• Grade 4: Completely disabled; cannot carry out any self-care; totally confined to bed or chair
• Active cachexia management deemed not clinically appropriate or futile by treating oncologist
• Estimated life expectancy \<3 months per treating oncologist's assessment
• Imminent end-of-life care or transition to hospice care 3. Uncontrolled Comorbid Conditions
• Uncontrolled diabetes mellitus defined as:

Sponsors & Collaborators

• King Edward Medical University: lead

Study Sites (1)

Department of Radiotherapy and Medical Oncology, Mayo Hospital Lahore, 54000, Lahore, Pakistan.

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (3)

• Roeland EJ, Bohlke K, Baracos VE, Bruera E, Del Fabbro E, Dixon S, Fallon M, Herrstedt J, Lau H, Platek M, Rugo HS, Schnipper HH, Smith TJ, Tan W, Loprinzi CL. Management of Cancer Cachexia: ASCO Guideline. J Clin Oncol. 2020 Jul 20;38(21):2438-2453. doi: 10.1200/JCO.20.00611. Epub 2020 May 20.

  PMID: 32432946 RESULT

• Ng KLS, Munisamy M, Lim JBY, Alshagga M. The Effect of Nutritional Mobile Apps on Populations With Cancer: Systematic Review. JMIR Cancer. 2025 Feb 5;11:e50662. doi: 10.2196/50662.

  PMID: 39908548 RESULT

• Muscaritoli M, Arends J, Bachmann P, Baracos V, Barthelemy N, Bertz H, Bozzetti F, Hutterer E, Isenring E, Kaasa S, Krznaric Z, Laird B, Larsson M, Laviano A, Muhlebach S, Oldervoll L, Ravasco P, Solheim TS, Strasser F, de van der Schueren M, Preiser JC, Bischoff SC. ESPEN practical guideline: Clinical Nutrition in cancer. Clin Nutr. 2021 May;40(5):2898-2913. doi: 10.1016/j.clnu.2021.02.005. Epub 2021 Mar 15.

  PMID: 33946039 RESULT

MeSH Terms

Conditions

Cachexia; Neoplasms; Sarcopenia

Condition Hierarchy (Ancestors)

Weight Loss; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Thinness; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Muhammad Abbas Khokhar

Study Record Dates

• First Submitted: May 19, 2026
• First Posted: May 26, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: June 8, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)